FDA panel votes to ease rules on unapproved peptides despite scientific warnings

FDA scientists advised against easing restrictions on experimental peptides in July, but a newly appointed advisory panel voted to loosen those rules. The disagreement centers on a temporary access policy published on a White House docket on Oct. 14, which proposes allowing licensed pharmacies to manufacture and sell specific unapproved peptides.

The policy follows a push by Health and Human Services Secretary Robert F. Kennedy Jr. and leaders of the Make America Healthy Again movement to increase access to longevity treatments. The FDA panel’s vote to loosen restrictions drew scrutiny because many members are new appointees with financial interests in the peptide industry. Emily Hilliard, a Department of Health and Human Services spokesperson, stated in an email that all committee members meet the agency’s ethics requirements.

Haleem Mohammed, the chief medical officer of Gameday Men’s Health, a men’s clinic that sells peptides, voted in favor of the measure. “I voted ‘yes’ for patient safety, the greater good, and medical freedom,” Mohammed said at the July FDA meeting. The agency is considering lowering restrictions on BPC-157 and five other experimental peptides that lack high-quality clinical trials.

Promoters of these substances often argue they are safe because they are natural or produced by the human body. However, Katrin Svensson, a peptide scientist at Stanford University, noted that BPC-157 is not found in the human genome. “Natural things can be toxic,” Svensson said, citing insulin overdoses as an example of natural substances causing harm.

Claims that peptides treat specific illnesses are widespread among influencers and practitioners, including Kris Wusterhausen, a new FDA appointee and founder of an antiaging company. Wusterhausen has claimed BPC-157 treats acid reflux and neurologic disorders. A 2025 review of research on musculoskeletal injuries warned that the evidence is insufficient. Flynn McGuire, a physical rehabilitation doctor at the University of Utah, said he will not prescribe BPC-157 until quality studies are completed.

A common misconception is that peptides cannot be patented, a view suggested by Kennedy on social media. Hundreds of peptide patents exist in the U.S. Patent and Trademark Office database. Jacob Sherkow, a professor of law at the University of Illinois Urbana-Champaign, explained that while natural substances are not patentable, modifications and formulations are. The pharmaceutical trade organization PhRMA advised the FDA against the policy, arguing it would erode incentives for manufacturers to undertake the time and cost required for approval.

The debate occurs against a backdrop of high healthcare costs in the United States. A recent KFF poll found that six in 10 U.S. adults worry about affording prescription drugs, and four in 10 have skipped doses due to price. While leaders of the MAHA movement correctly note that the U.S. ranks below other wealthy nations in life expectancy, researchers have not listed skipping clinical trials among recommended policies to improve public health.